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Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials Market Access

Starts & Stops: ICS' Emblok Medtronic's Arctic Front, Abbott's Absorb, Boston Scientific's S-ICD

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.

Clinical Trials Research & Development Starts & Stops

New EU Regs Will Offer No Reprieve From Borderline Classification Chaos

Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.

Combination Products Europe Regulation

Device Week – April 21, 2017

On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.

Commercial Deals Medical Device
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Policy & Regulation Explore this Topic

Set Alert for Policy

Medtronic StratMR Device Gets Class I Recall

Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.

Recalls Safety Quality Control

US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle Management Quality Control Compliance

AdComms To Meet On TransMedics Organ Transplant Device, Discuss '21st Century' Funds

Two US FDA advisory committee meetings are scheduled for May. One will delve into a new organ-transplant device intended to keep organs viable longer, while the other will present recommendations on how the agency should spend funds from the 21st Century Cures Act.

FDA Advisory Committees

Device Trade Groups Offer Lukewarm Comments On Pre-RFD Draft

BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.

Combination Products Review Pathway

Stakeholders Support OTC Hearing Aids At FTC Summit

Most stakeholders speaking and participating in panels during the Federal Trade Commission’s April 18 workshop on hearing aids expressed support for over-the-counter sales of the devices, though several expressed reservations about how to best protect patients.

Ear Regulation

New Bodies To Emerge Under Revised EU Governance Structure

What is the governance structure under the forthcoming new EU Medical Device and IVD Regulations? Here, Medtech Insight attempts to answer that question and explain how the different organizations and groups relate.

Europe Regulation

Warning Letter Roundup & Recap – April 18, 2017

An Abbott plant manufacturing St. Jude Medical cardiac products was slapped with a warning for quality systems issues in the only warning letter released the week of April 18.

Device Warning Letters Regulation

Initial Survey Results Show Overwhelming Satisfaction With FDA Device Center Customer Service

While there are still a few months to go before the US FDA's Center for Devices and Radiological Health closes its customer service survey, the initial results look to be trending in the agency's favor. With almost nine-in-ten respondents giving a positive review, the results support the agency's efforts to improve customer service.

FDA Medical Device

Quality Control Explore this Topic

Latest From Quality Control

US FDA Warning Letter Scrutinizes Abbott Over Cybersecurity, Battery Lapses

FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.

Regulation Compliance

Artificial Intelligence Center To Offer Quality, Regulatory Solutions

In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says. Also: will AI steal human jobs?

Quality Quality Control

Mylan’s EpiPen Recall: Another Hit On The Auto-Injector

What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.

Safety Combination Products

Commercial Explore this Topic

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DePuy Synthes Builds Out Trauma Offering With TRS' 3D-Printed Tech

Underlining its focus on 3D-printing and the potential this technology can bring, DePuy Synthes has acquired the 3D-printed scaffold platform of Tissue Regeneration Systems, enabling the orthopedics leader to develop patient-specific trauma products in-house.

Orthopedics M & A Deals

Latest From Commercial

STAT-DX Aims To Take On Rival BioFire In Syndromic Testing

Barcelona start-up STAT-DX is gearing up to launch a new decentralized multiplex PCR system in the rapidly growing field of syndromic testing. The company, which will face larger rivals such as bioMérieux's BioFire, will unveil its new point-of-care platform at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Vienna from 22-25 April.

Infectious Diseases In Vitro Diagnostics

Cellnovo Targets 2018 Launch Of Insulin Micropump With Artificial Pancreas Tech

Cellnovo has signed a commercial license agreement with digital health firm TypeZero to integrate its artificial pancreas software technology into Cellnovo’s digitally connected insulin patch pump. The integrated product is expected to launch in 2018.

Deals Diabetic Care

Cardinal Health, Medtronic Tie Up $6.1bn Lower-Margin Assets Deal

Medtronic is selling certain lower-margin, lower growth assets within its Patient Monitoring and Recovery division to Cardinal Health in a $6.1bn deal. While the deal may benefit Medtronic's debt situation, the same cannot be said for the buyer.

M & A Deals

Despite Legal Dispute, Abbott Set To Buy Alere for $5.3bn

Soon before it was set to take Alere to court in an attempt to break out of an acquisition deal, Abbott has reversed course and plans to buy the company for half a billion less than the original price tag.

M & A Legal Issues

Imanova Seeks More Partners For Imaging-Aided Fight Against Neurodegen Disease

With another fresh injection of funds from the UK Medical Research Council, imaging services provider Imanova is advancing to the next stage of its MIND-MAPS program that aims to identify novel early markers of progression of neurodegenerative diseases, including Alzheimer's and Parkinson's. The data generated from the program could be used to help Imanova's pharma partners develop new therapies to tackle these diseases.

Neurology Diagnostic Imaging

Inside The Spinal Cord: InVivo Therapeutics Looks To Reverse Injury, Leverage Regulatory Reforms

InVivo Therapeutics is looking to build on a breakthrough in understanding the pathophysiology of spinal cord injury to bring the first device to market for partially reversing the debilitating condition. The firm is dealing with a cautious FDA in its pivotal-trial development, but also looking to leverage a new US policy for humanitarian-use devices to expedite its path to market expansion.

Neurology Innovation

Clinical R&D Explore this Topic

Set Alert for Clinical R

Start-Up Spotlight: Amniox Medical, Bringing The Benefits Of Amniotic Tissue To Ortho And Wound Care

Amniox Medical is developing biologics products for wound-healing and orthopedic applications based on technology that takes advantage of the unique anti-inflammatory and anti-scarring properties of human amniotic membrane and umbilical cord matrix.

Regenerative Medicine Wound Healing & Tissue Repair Orthopedics

Latest From Research & Development

Edwards Gets Early Present With FDA Clearance

While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.

Cardiovascular Cardiology

ElectroCore's gammaCore Gets US Clearance For Cluster Headaches

The de novo clearance is the first US clearance for electroCore's non-invasive vagus nerve stimulation therapy. The company will market it through headache specialists as a non-pharmacological alternative to sumatriptan for patients with cluster headaches, which afflict about 350,000 people in the US.

Neurology Innovation

Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota

This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.

Research & Development Clinical Trials

Game On For Akili's Cognitive Control Tech

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD). The company is also anticipating a market launch of the device for pediatric attention deficit hyperactivity disorder in 2018.

Digital Health Neurology

Philips' eICU Telemedicine Program Yields Cost Savings, Slows Readmissions For Emory

Five Emory University-affiliated hospitals taking part in a Philips eICU program cut total costs by $4.6m – or $1,468 per average care episode – reduced discharges to nursing homes by 6.9%, and lowered inpatient readmission rates, according to a recent audit by CMS contractors.

Reimbursement Medicare

Clinical Data Double-Boost Supports Medtronic's HeartWare Investment

Results of the LATERAL trial presented at the recent ISHLT conference show Medtronic's HVAD can be implanted safely through a thoracotomy procedure instead of the standard sternotomy approach, which is far more invasive. At the same meeting, subset data from the ENDURANCE trial confirms that the sickest heart-failure patients treated with HVAD have similar outcomes as less sick patients, and results of the ENDURANCE Supplement show that blood pressure management minimizes the risk of stroke with HVAD.

Cardiology Cardiovascular
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